The Clinical Trial Research Coordinator II (CTRC-II) is a position that supports (among other FDA-regulated clinical trials) the Children’s Oncology Group (COG), a National Cancer Institute supported clinical trials group that is the world’s largest organization devoted exclusively to childhood and adolescent cancer research. The COG unites more than 10,000 experts in childhood cancer at more than 200 leading children’s hospitals, universities, and cancer centers across North America, Australia, New Zealand, and Europe in the fight against childhood cancer. COG research has turned children’s cancer from a virtually incurable disease 50 years ago to one with a combined 5-year survival rate of 80% today, and has a goal to cure all children and adolescents with cancer, reduce the short and long-term complications of cancer treatments, and determine the causes and find ways to prevent childhood cancer.

The Clinical Trial Research Coordinator II (CTRC-II) is a position w/demonstrated proficiency in coordinating clinical trial research tasks which, under the clinical direction of the Principal Investigator (PI), provides research, operational, & administrative support to the KP NCAL PI & KPNC Clinical Trials Operations Dir or designee, & other research staff conducting multiple FDA-regulated clinical trials. The CTRC-II is a hands-on position responsible for conducting the day-to-day activities of clinical trial project(s) under the supervision of the PI. The CTRC-II works more independently, assumes increased clinical trial responsibilities & requires periodic supervision. This is a non-licensed position which works under the daily supervision of an experienced Clinical Trial Nurse, Clinical Trial Research Coordinator, &/or KFRI-designated, licensed clinical trial research staff member. This position must adhere to the position's scope of practice as outlined in the Major Responsibilities below. This position is also responsible for assisting in protecting the health, safety, & welfare of research participants.

Essential Functions:

• Compliance Support & comply w/the Principles of Responsibility (KP Code of Conduct). W/guidance from PI, ensure compliance w/ KPNC IRB Standard Operating Procedures (SOP) & document applications. Adhere to Guideline for Good Clinical Practice (GCP), federal, state, & local regulations, & KP policies & procedures W/supervision, prepare for inspections, audits & monitor visits.

• Study Implementation Maintain the security & confidentiality of participants' paper or electronic data (e.g., case report forms kept in a secure, locked space). Direct issues requiring medical decision-making to the appropriate licensed staff member promptly. According to protocol &/or IRB-approved telephone script, collect & document research data & report the information to the appropriate licensed staff member & PI for assessment in a timely manner. Coordinate & schedule participants for study assessments/visits, required tests, including visit specific lab kits &/or paperwork preparation, etc. Prepare packets for participants (e.g., instructions, phone numbers, calendars, diaries, etc.). W/appropriate guidance, obtain & review medical records & test results of all project/study participants & abstract needed data per protocol requirements. W/guidance from PI, complete case report forms (paper or electronic) & maintain a database program to track all study activity including study enrollment & consents. Respond to Sponsor to resolve data queries & delinquencies in a timely manner. Report any potential protocol violations/deviations to the PI in a timely manner. Assist in the collection of protocol required data w/ timely & accurate submissions as required by Sponsor (e.g., weekly screening log, routine electronic data submissions). Coordinate & prepare protocol specimens for shipping or storage in accordance w/ IATA/DOT regulations & Sponsor shipping guidelines. Assist w/ participant's long-term follow-up data collection. Assist PI &/or Clinical Trial Nurse, if applicable, w/ identifying, screening, & recruiting potential participants. Provide PI &/or Clinical Trial Nurse w/ the ongoing informed consent process by coordinating the current consent documents. Assist in study closure activities including preparation & collection of close-out documentation, & preparation of study files for distribution to longterm storage. W/guidance, receive, disseminate & maintain study-related communications w/ internal & external parties involved w/clinical trial protocols.

• This job description is not all encompassing.

Basic Qualifications:Experience- One (1) year of experience in clinical trials research OR a bachelor's degree required.- Bachelor's degree may be substituted for 1 year work experience.Education- Associates degree or higher OR two (2) years of work experience in an ambulatory and/or acute health care setting required (LVN maybe substituted for an Associate's degree).- High School Diploma or General Education Development (GED) required.License, Certification, Registration- N/A.

Additional Requirements:- Willingness to obtain IATA/DOT certification. - Current BLS certification required prior to start date. - Satisfies requirements for career advancement as defined by the Clinical Trial Career Ladder Program. - Must be proficient in electronic health systems and data bases used in research environment and word-processing and database software or willingness to learn within 3 months of hire. - Demonstrate organizational and communication skills. - Demonstrate written, verbal, and interpersonal communication skills - Demonstrate proficiency in medical terminology. - Attention to detail and accuracy. - Ability to manage multiple tasks Demonstrate prioritization skills. - Demonstrate problem-solving skills. - Demonstrate project management skills. - Ability to be flexible and dependable. - Possess ability to work effectively on cross-functional teams. - Present professional manner and appearance. - Possess ability to abstract pertinent protocol data from medical record. - Skill in administrative tasks (i.e., filing, photocopying, faxing, etc.). - Knowledge of the principles, methods and procedures of basic medical and/or clinical research processes. - Knowledge and understanding of human research protection regulations, policies, procedures, and standards as applied to IRB and compliance operations. - Knowledge of clinical trials research and research regulations, as well as clinical trial experience in a specific therapeutic area. - Knowledge of GCP, federal, state, and local regulations including HIPAA and KP policies and procedures. - Must be able to work in a Labor Partnership environment.

Preferred Qualifications:- Current ACRP or SoCRA certification preferred.

COMPANY: KAISER

TITLE: Clinical Trial Research Coordinator II

LOCATION: Oakland, California

REQNUMBER: 1174250

External hires must pass a background check/drug screen. Qualified applicants with arrest and/or conviction records will be considered for employment in a manner consistent with Federal, state and local laws, including but not limited to the San Francisco Fair Chance Ordinance. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, sexual orientation, gender identity, protected veteran, or disability status.